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Treatment of Youth with ADHD and Anxiety Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Treatment of Youth with ADHD and Anxiety conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Treatment of Youth with ADHD and Anxiety Clinical research trials and Treatment of Youth with ADHD and Anxiety healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Treatment of Youth with ADHD and Anxiety. Treatment of Youth with ADHD and Anxiety Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Treatment of Youth with ADHD and Anxiety clinical trial. Human subjects often obtain the finest healthcare possible for their Treatment of Youth with ADHD and Anxiety condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Treatment of Youth with ADHD and Anxiety  Treatment of Youth with ADHD and Anxiety
Treatment of Youth with ADHD and Anxiety
For Condition: Anxiety, Separation,Social Phobia,Attention Deficit Hyperactivity Disorder,Generalized Anxiety Disorder
Status: No longer recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this NIMH-sponsored pilot study is to collect information on the efficacy and safety of drug treatments for children and adolescents who suffer from both ADHD and anxiety disorders. Specifically, the study will examine the benefits of the stimulant medication both alone and in combination with fluvoxamine, a selective serotonin reuptake inhibitor (SSRI) that has antianxiety effects. Young people aged 6 to 17 diagnosed with these co-occurring disorders may be eligible to participate.
Details: Many children and adolescents with mental disorders in the United States are treated with multiple psychotropic medications even though there is not much information on how well these medications work together or if they are safe to administer together. Many youth with ADHD have co-occurring (comorbid) disorders such as oppositional-defiant disorder, anxiety disorders, and mood disorders. There is much interest in the treatment of children and adolescents with comorbid ADHD and anxiety disorders because this is a common condition in clinical practice. When children with both anxiety and ADHD receive stimulant medication for ADHD, their anxiety may not improve. SSRI medications represent a reasonable addition to stimulant treatment, as they are considered effective for anxiety disorders based on controlled trials in adults and open trials in children. However, there are no data from controlled studies regarding the tolerability and dosing of the combination of stimulant treatment (including methylphenidate) and SSRIs in the treatment of children with comorbid ADHD and anxiety disorder. In this study, children and adolescents will be evaluated for the presence of both ADHD and Anxiety Disorder. Approximately 120 children and adolescents with both disorders who meet all the study entry requirements (such as being otherwise medically healthy) will be enrolled. Children and adolescents who are not on a stable dose of a stimulant will first be treated openly with methylphenidate for 6 weeks. Those whose ADHD does not improve during this initial treatment period will not continue in the study but will be referred for further support in the community. Those who show improvement in both their ADHD and anxiety symptoms will stay on methylphenidate for an additional 8 weeks. Those who show improvement in ADHD but not anxiety will be asked to enter the double-blind phase of the study. In this phase, participants will be randomized (assigned by chance) to receive either fluvoxamine or placebo, in combination with stimulant/methylphenidate, for 8 weeks. Children or adolescents who enter the study on a stable dose of stimulant will move directly to the Double-Blind phase. Participants who are assigned to placebo and who do not show an improvement in anxiety after 8 weeks will be eligible for an additional 8 weeks of open treatment with the methylphenidate/stimulant and fluvoxamine combination. At the end of the trial, clinical care will be provided for up to an additional month until referral to an outside clinician can be arranged.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 6 Years/17 Years
Genders: Both
Protocol Entry Criteria: -ADHD diagnosis - DSM-IV diagnosis of anxiety - IQ greater than 70 - residence with primary caretaker for at least 6 months - ages 6-17 and attending school - no previous treatment failure to or intolerance of fluvoxamine or methylphenidate (unless currently taking another stimulant)
Total Enrollment: 120
Location and Contact Information:
New York State Psychiatric Institute
New York City, New York, 10032
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
New York University Child Study Center
New York City, New York, 10016
United States
UCLA Neuropsychiatric Institute
Los Angeles, California, 90095
United States
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
United States
Additional Information:
Study ID Numbers: NO1MH12012;
Study Start Date: March 2001
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012584
Other Generalized Anxiety Disorder Studies:
1. Treatment of Social Phobia
2. Treatment for Anxiety in Children
3. Treatment of Youth with ADHD and Anxiety
Related Studies:
Other Generalized Anxiety Disorder Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Treatment of Youth with ADHD and Anxiety
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